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DCprime announces first patient dosed in phase 2 ADVANCE-II study with DCP-001 in patients with Acute Myeloid Leukemia

On November 15, 2018 DCprime bv, a clinical stage biotechnology company focused on cancer immunotherapies, reported that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II (Press release, DCPrime, NOV 15, 2018, View Source [SID1234531456]). Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.

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Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: "We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse."

The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.

Dr Jeroen Rovers, Chief Medical Officer at DCprime added: "Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study."

Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).

Nanobiotix revenues for the 3rd quarter of 2018

On November 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the third quarter of 2018 (Press release, Nanobiotix, NOV, 15, View Source [SID1234531455]).

Activity and results
Total revenue for the third quarter of 2018 amounted to € 21,816. This brings total revenue for the first nine months of 2018 to € 95,120, which is in line with the Company’s expectations.
All of the revenues generated by the Company during the third quarter of 2018 come from services that Nanobiotix
crossed-charged to its partners in accordance with our agreed upon development program operational activities.
In July 2018, Nanobiotix launched a non-dilutive financial partnership with the European Investment Bank (EIB) to boost its research, development and innovation activities. The financing agreement permits the Company to borrow up to €40 million in loans from EIB over the next five years subject to the Company’s achievement of a set of agreed performance criteria. We expect this financing agreement to enable Nanobiotix to accelerate both the development of the Company’s NBTXR3 clinical trial in advanced Head and Neck cancers and to support its European go-to-market strategy.

In September 2018, Nanobiotix presented an update on data from its NBTXR3 development program at the International Conference on Immunotherapy Radiotherapy Combinations. The presentation included updated data related to the Company’s follow-up for its Phase I/II clinical trial in advanced Head and Neck cancers in elderly and frail patients ineligible for cisplatin or intolerant to cetuximab. The data suggests the potential of NBTXR3 to impact survival for this advanced cancer patient population. In addition, the Company presented data obtained from the immuno biomarker study in its randomized Phase II/III clinical trial in soft tissue sarcoma. This data indicated that NBTXR3 activated by EUI- 1202982973v22 radiation therapy could modulate the antitumor immune response.
Finally, the Company’s in vivo investigation of NBTXR3’s mode of action inducing distant immune response on CT26
tumoral model produced data that continues to support the rationale for the use of NBTXR3 activated by radiation
therapy to seek to transform tumors into an in situ cancer vaccine and its potential use in combination with
immunotherapeutic agents.
***
Next financial press release: revenue for Q4 2018 by February 28, 2019
About NBTXR3
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
• tumors through physical cell death
• metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and
Nanobiotix believes it has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient populations evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III
clinical trial.
NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or
oropharynx in elderly and frail patients that are unable to receive chemotherapy or cetuximab and have very limited therapeutic
options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of tumors.
Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the
U.S. Food and Drug Administration (FDA) to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1
antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).
The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally
advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and prostate adenocarcinoma.
The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.

Diffusion Pharmaceuticals Chief Scientific Officer Dr. John L. Gainer to Present at 2018 Annual Meeting of the Society for NeuroOncology

On November 15, 2018 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, reported that Chief Scientific Officer Dr. John L. Gainer will join leading clinicians and researchers from around the world in presenting a poster at the 2018 Annual Meeting of the Society for NeuroOncology (SNO) on Saturday, November 17, 2018 from 5:00-7:00pm EST (Press release, Diffusion Pharmaceuticals, NOV 15, 2018, View Source [SID1234531433]).

SNO’s 23rd Annual Scientific Meeting and Education Day will be held from Thursday, November 15, 8:00am through Sunday, November 18, 1:00pm at the Marriott Hotel, New Orleans, Louisiana. SNO is a "multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education" whose annual conference is an opportunity for top health care professionals who specialize in central nervous system tumors to gather and present the latest advancements to fellow researchers, hospital administrators, and potential investors.

Dr. Gainer, who in addition to serving as the Chief Scientific Officer of Diffusion is also the inventor of Trans Sodium Crocinate (TSC), will present a poster on the Company’s Phase 3 INTACT (INvestigation of TSC Against Cancerous Tumors) clinical trial for the treatment of glioblastoma multiforme (GBM) brain cancer in biopsy-only patients. Phase 2 of Diffusion’s INTACT trial showed potentially breakthrough results in the use of TSC in treatment: a fourfold increase in the two-year survival rate of biopsy-only patients, which jumped from 10 percent to 40 percent. This result is especially promising for these patients and their families: biopsy-only patients have historically faced lower survival rates than patients for whom resection (surgery for removal of the tumor) is an option.

"Dr. Gainer’s focus on innovation is what drew me to his research in the first place, and resulted in our co-founding of Diffusion, where we continue our efforts to find new and effective treatments for life-threatening diseases like GBM brain cancer," said David Kalergis, Chairman and CEO of Diffusion. "At the 2018 Annual Meeting of the Society of NeuroOncology, Dr. Gainer will have an opportunity to present the exciting results from our Phase 2 GBM cancer trial and share our continued Phase 3 efforts for biopsy-only participants – work which represents real potential and promise for patients and their families"

"Finding effective and life-saving treatment for patients living with biopsy-only GBM brain cancer has long been a significant challenge for researchers, scientists, and physicians, so I’m looking forward to my poster presentation at the 2018 Annual Meeting of the Society of NeuroOncology, as it’s a chance to share the progress we’ve made on this front," said Dr. John L. Gainer, Chief Scientific Officer of Diffusion. "Hypoxic tumors are resistant to radiation therapy, and our Phase 2 results showed that using TSC – which was developed to fight hypoxia by bringing oxygen to the areas where it’s needed most – in conjunction with radiation and temozolomide (TMZ) treatment led to a significant increase in survival for biopsy only patients. Our Phase 3 study will focus on these biopsy-only patients, and I am eager to share that work with my colleagues from around the world at SNO’s 2018 Annual Meeting."

Diffusion’s Phase 3 INTACT program is using TSC to target inoperable GBM brain cancer. Historically, these biopsy-only patients have faced lower survival rates and increased obstacles to inclusion in clinical trials. Current standard of care for these GBM patients following diagnosis involves 6 weeks of radiation therapy along with daily temozolomide (TMZ), followed by six 4-week chemotheraphy sessions which include a high dosage of TMZ. Phase 2 of INTACT saw treatment with TSC added to the initial six weeks of radiation therapy and TMZ treatment. Phase 3 of INTACT will include treatment with TSC during the initial six week of radiation therapy and TMZ treatment, but will also include administration of TSC during the six months of chemotheraphy. The Company is currently engaged in an FDA-requested, 8-patient lead-in, scheduled to complete in January 2019. Randomization can begin following read out and reporting of that data."

Dr. Gainer’s presentation at SNO is just the latest development for Diffusion, which recently received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke. The Company also recently appointed William "Bill" Hornung to the position of Chief Financial Officer.

BIO-PATH HOLDINGS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS

On November 15, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2018 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2018, View Source [SID1234531429]).

"Throughout the third quarter, we continued to make meaningful progress advancing and expanding our robust clinical development pipeline of RNAi nanoparticle drugs to bring innovative new treatments to cancer patients with high unmet medical need," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Most recently, we were delighted to report that interim data from our ongoing Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia (AML) were accepted for poster presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) taking place in early December 2018. This is an exciting opportunity to showcase this very promising program as earlier studies showed 47% of evaluable patients demonstrated some degree of response to prexigebersen in combination with LDAC in this patient population. In addition, we were pleased to report the dosing of the first patient in Stage 2 of this Phase 2 clinical trial where, at the recommendation of the study’s principal investigators, we are implementing a change in the dosing regimen administering a higher dosing of prexigebersen prior to starting treatment with LDAC. We also initiated a cohort of the Phase 2 AML trial assessing prexigebersen in combination with decitabine. We look forward to having interim results from these cohorts next year.

"We are also making progress expanding our clinical programs beyond AML. Enrollment in our global Phase 2 clinical trial of prexigebersen for the treatment of chronic myeloid leukemia (CML) continues apace and we continue to advance work on an Investigational New Drug (IND) application for prexigebersen for the treatment of solid tumors. In addition, we plan to submit an IND application by year-end to begin studies of our second drug candidate, BP1002, which targets Bcl-2 for the treatment of lymphoma and CLL. Finally, we continue our work to advance our third investigation drug candidate, BP1003, in pancreatic cancer. Toward that end, we were especially pleased to welcome Jason Fleming, MD, FACCP, to our Scientific Advisory Board (SAB). Dr. Fleming is a renowned gastrointestinal cancer specialist whose insight and guidance will be of particular value to the development of this clinical program.

"The considerable progress made in 2018 provides the foundation from which we expect to build and advance our new pathway in DNA-powered medicines into 2019 and beyond," concluded Mr. Nielsen.

Recent Corporate Highlights

·Interim data from the ongoing Phase 2 clinical trial of prexigebersen for the treatment of AML accepted for poster presentation at ASH (Free ASH Whitepaper) 2018. In November 2018, Bio-Path announced that data from its ongoing Phase 2 clinical trial of prexigebersen will be presented at ASH (Free ASH Whitepaper) 2018 by Maro Ohanian, MD, Assistant Professor of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, before an audience of the world’s leading blood cancer specialists.

·Commenced Stage 2 of the Company’s Phase 2 trial of prexigebersen in AML. In August 2018, Bio-Path announced the dosing of the first patient in the open-label Phase 2 study evaluating the efficacy and safety of prexigebersen in conjunction with LDAC and a second cohort of prexigebersen and decitabine, both therapeutic regimens well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether these combinations with prexigebersen provides greater efficacy than what would be expected with LDAC or decitabine alone in this de novo patient population.

·Appointed Dr. Fleming to the Company’s Scientific Advisory Board. In August 2018, Bio-Path appointed Dr. Fleming, a world-leading gastrointestinal cancer expert, to its SAB. Dr. Fleming offers substantial insight as the Company seeks to advance its lead drug candidate, prexigebersen, and its third drug candidate, BP1003, towards the clinic for the treatment of pancreatic cancer.

·Raised $1.5 million in a registered direct offering. In September 2018, Bio-Path issued and sold 2,261,538 shares of its common stock (or common stock equivalent) for a price of $0.65 per share, for gross proceeds of approximately $1.5 million. Additionally, in a concurrent private placement, Bio-Path issued to such investors unregistered warrants to purchase up to 2,261,538 shares of common stock with an exercise price of $0.96 per share and an exercise period commencing six (6) months following the issuance date and a term of five and one-half (5.5) years from the date of issuance.

Financial Results for Third Quarter Ended September 30, 2018

·The Company reported a net loss of $3.1 million, or $0.27 per share, for the three months ended September 30, 2018, compared to a net loss of $2.5 million, or $0.25 per share, for the three months ended September 30, 2017.

·Research and development expenses for the three months ended September 30, 2018 increased to $2.3 million, compared to $1.6 million for the three months ended September 30, 2017 primarily due to costs related to the release of drug material for our Phase 2 clinical trials for prexigebersen in AML and CML.

·General and administrative expenses for the three months ended September 30, 2018 decreased to $0.7 million, compared to $0.9 million for the three months ended September 30, 2017 primarily due to decreased legal and audit fees.

·As of September 30, 2018, the Company had cash of $2.3 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the nine months ended September 30, 2018 was $4.8 million compared to $5.7 million for the comparable period in 2017. Net cash provided by financing activities for the nine months ended September 30, 2018 was $1.2 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2018 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 8564777. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

Aradigm Announces Third Quarter 2018 Financial Results

On November 15, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the third quarter and nine months ended September 30, 2018 (Press release, Aradigm, NOV 15, 2018, View Source [SID1234531428]).

Third Quarter 2018 Financial Results

The Company recorded $282,000 in revenue in the third quarter of 2018 compared with $2.7 million in revenue in the third quarter of 2017. The Company recognized $170,000 in contract revenue-related party, $52,000 in government contract revenue and $60,000 in government grant revenue for the third quarter of 2018, as compared to $2.7 million in contract revenue-related party, $6,000 in government contract revenue and $13,000 in government grant revenue for the third quarter of 2017.

Total operating expenses for the third quarter of 2018 were $2.8 million, compared with total operating expenses of $5.7 million for the third quarter of 2017. The decrease in research and development expenses of $2.0 million was due to a lower regulatory spend in support of Linhaliq during the ongoing EMA review process of the validated MAA submission and our ongoing interaction with the FDA to address the issues raised in their complete response letter dated 26 January 2018. The decrease in research and development expenses for the quarter was also due to lower employee related expenses from a reduction in headcount. The decrease in general and administrative expenses of $0.9 million was primarily related to lower legal expenses, lower consulting expenses and lower employee-related expenses due to a reduction in headcount.

Net loss for the third quarter of 2018 was $3.6 million or $(0.24) per share, compared with a net loss of $3.9 million or $(0.26) per share in the third quarter of 2017. For the quarter ended September 30, 2018, the net loss decreased by $0.3 million primarily from a decrease in operating expenses of $2.9 million offset by a decrease in revenue of $2.4 million and an increase of $0.2 million in other interest expense.

Liquidity and Capital Resources and Related Matters

As of September 30, 2018, the Company reported cash and cash equivalents of $2.9 million. During the second and third quarters of 2018 Aradigm raised an aggregate of approximately $7.0 million through the issuance and sale of promissory notes. In October 2018, Aradigm entered into an additional note purchase agreement for the issuance and sale of approximately $4 million in promissory notes, of which $2.0 million of promissory notes were issued and sold on October 25,

2018. Subject to the satisfaction of certain conditions, the Company anticipates that an additional closing for the issuance and sale of $2.0 million of promissory notes will occur prior to December 31, 2018. The Company believes that the $2.0 million received in October along with the cash balance of $2.9 million will be sufficient to fund operations through the fourth quarter of 2018. Aradigm is pursuing potential alternatives to resolve our cash position in the short-term as well as developing strategic options that would provide for our long-term viability. However, no assurance can be given that we will be successful in raising such additional capital on favorable terms or at all. Not achieving such funding on a timely basis would materially harm our business, financial condition and results of operations and could require us to delay or reduce the scope of all or a portion of our development programs, dispose of our assets or technology or to cease operations entirely.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the US. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition